Controlled urinary incontinence treatment

0001This application is a Continuation Application of U.S. application Ser. No. 10/203,094, filed Oct. 16, 2002 now U.S. Pat. No. 7,648,455 which is the U.S. National Phase of International Application No. PCT/SE01/00252, filed Feb. 8, 2001, which designated the U.S., and which claims the benefit of Provisional Application Ser. No. 60/181,465, filed Feb. 10, 2000, and Provisional Application Ser. No. 60/181,466, filed Feb. 10, 2000, the entire contents of each of which are hereby incorporated by reference herein.

0002The present invention relates to a urinary incontinence treatment apparatus, comprising a restriction device implantable in a patient suffering from urinary incontinence for engaging the urethra or urine bladder to form a restricted urine passageway in the urethra or urine bladder, wherein the restriction device is operable to change the restriction of the urine passageway.

0003Urine incontinence is a widespread problem. Many people are helped through training of the muscles in the pelvic floor but too many have severe problems with urine leakage. Many different solutions to this problem have been tried. For example, there is a prior manually operated urine incontinence treatment apparatus having an artificial hydraulic sphincter device engaging the urethra and connected to an elastic reservoir implanted in the scrotum or in the region of the labia majora. A disadvantage of this prior apparatus is that over time hard fibrosis is developed around the reservoir which may cause malfunction of pumping components. Furthermore, it is a rather complicated task to manually squeeze the elastic implanted reservoir to pump hydraulic fluid to open the sphincter device when the patient needs to urinate. In particular women can get their fingers wet. The created fibrosis will sooner or later become a hard fibrotic layer, which may make it even more difficult to pump the reservoir. Yet a further disadvantage is that the use of hydraulic fluid always entails a risk of fluid leaking from implanted hydraulic components.

0004A prior hydraulic apparatus designed to compress the urethra is disclosed in U.S. Pat. No. 5,520,606. Prosthetic sphincters with an inflatable cuff, which surrounds the urethra or encloses it on two sides is disclosed in for example U.S. Pat. Nos. 4,571,749 and 4,222,377. U.S. Pat. No. 4,969,474 discloses a hydraulic method for treating both men and women with urinary incontinence problems in the same way. The apparatus of U.S. Pat. No. 4,969,474 includes a reservoir containing fluid and an inflatable compression means designed to compress urethra without risking tissue loss or necrosis to occur. An artificial hydraulically operated urethral sphincter employing an external magnet to achieve closure of the urethral cuff is disclosed in U.S. Pat. No. 5,562,598.

0005A prior mechanical prosthetic sphincter, disclosed in U.S. Pat. No. 4,619,245, comprises a manually controllable actuating component for implanting at a convenient location in the patients body.

0006The object of the present invention is to provide a new convenient urinary incontinence treatment apparatus, the performance of which may be affected by the patient at any time after operation, in particular when various needs arise over the course of a day, so that the patient substantially always is satisfied or comfortable.

0007This object is achieved by a urinary incontinence treatment apparatus of the kind stated initially, which is characterised in that a source of energy is provided, and a control device operable from outside the patient's body is provided for controlling the source of energy to release energy for use in connection with the operation of the restriction device, when the restriction device is implanted.

0008As a result, the advantage is achieved that the restriction device can be non-invasively operated, when the restriction device has to be adjusted. Furthermore, the apparatus of the invention provides a simple and effective control of the energy supplied to implanted components of the apparatus which ensures an extended and reliable functionality of the apparatus, possibly for the rest of the patient's life and at least many years.

0009The control device may also control the restriction device. The control device may comprise an internal control unit, preferably including a microprocessor, implantable in the patient for controlling the restriction device. The control device may further comprise an external control unit outside the patient's body, wherein the internal control unit is programmable by the external control unit, for example for controlling the restriction device over time. Alternatively, the internal control unit may control the restriction device over time in accordance with an activity schedule program, which may be adapted to the patient's needs.

0010A great advantage is that the patient is enabled to adjust the restriction of the urine passageway by using the control device whenever he likes during the day.

0011Conveniently, the external control unit may load the internal control unit with data in accordance with a loading mode only authorized for a doctor. For specialized controls of the restriction device, the external control unit may control the internal control unit in accordance with a doctor mode only authorized for the doctor. For simple controls of the restriction device, the external control unit may control the internal control unit in accordance with a patient mode permitted for the patient. Thus, by using the external control unit in accordance with different modes it is possible to have certain functions of the restriction device controlled by the patient and other more advanced functions controlled by the doctor, which enables a flexible post-operation treatment of the patient.

0012The control device may be adapted to control the source of energy to release energy, for instance to intermittently release energy in the form of a train of energy pulses, for direct use in connection with the operation of the restriction device. In accordance with a suitable embodiment the control device controls the source of energy to release electric energy, and the apparatus further comprises an implantable capacitor for producing the train of energy pulses from the released energy. In this case the term “direct” is used to mean, on one hand, that the released energy is used while it is being released by the control device, on the other hand, that the released energy may be somewhat delayed, in the order of seconds, by for instance an energy stabilizer before being used in connection with the operation of the restriction device. The restriction device may be operable in non-manual, a non-magnetic or non-mechanical manner by use of the released energy.

0013In accordance with a preferred embodiment of the invention, the apparatus comprises implantable electrical components including at least one, or only one single voltage level guard and a capacitor or accumulator, wherein the charge and discharge of the capacitor or accumulator is controlled by use of the voltage level guard. As a result, there is no need for any implanted current detector and/or charge level detector for the control of the capacitor, which makes the apparatus simple and reliable.

0014Generally, the apparatus further comprises an operation device implantable in the patient for operating the restriction device, wherein the control device controls the operation device to operate the restriction device. The control device may directly power the operation device with energy released from the source of energy and/or power other implantable energy consuming components of the apparatus. In this case the term “directly” is used to mean, on one hand, that the operation device is powered by released energy while the latter is being released by the control device, on the other hand, that the released energy may be somewhat delayed, in the order of seconds, by for instance an energy stabilizer before powering the operation device. The advantage of directly using energy as it is released is that the apparatus can be of a very simple design and the few components involved makes the apparatus reliable.

0015The control device may release magnetic, electromagnetic, kinetic, sonic or thermal energy, or non-magnetic, non-sonic, non-thermal, non-electromagnetic or non-kinetic energy.

0016However, preferably the operation device comprises an electrical operation device.

0017Typically the apparatus of the invention comprises an adjustment device for adjusting the restriction device to change the restriction of the urine passageway. The adjustment device may be adapted to mechanically adjust the restriction device. Alternatively, the adjustment device may be adapted to hydraulically adjust the restriction device by using hydraulic means which is devoid of hydraulic fluid of the kind having a viscosity that substantially increases when exposed to heat or a magnetic field, i.e. the hydraulic fluid would not become more viscous when exposed to heat or influenced by magnetic forces.

0018The restriction device may be non-inflatable, i.e. with no hydraulic fluid involved for the adjustments of the restriction device. This eliminates problems with fluid leaking from the restriction device.

0019The operation device may comprise hydraulic means and at least one valve for controlling a fluid flow in the hydraulic means. The control device may suitably comprise a wireless remote control for controlling the valve. The restriction device may comprise hydraulic means and the operation device may comprise a reservoir forming a fluid chamber with a variable volume connected to the hydraulic means. The operation device may distribute fluid from the chamber to the hydraulic means by reduction of the volume of the chamber and withdraw fluid from the hydraulic means to the chamber by expansion of the volume of the chamber.

0020In accordance with a first main aspect of the invention, the source of energy is external to the patient's body and the control device controls the source of energy to release wireless energy. The external source of energy may be of any conceivable kind, such as a nuclear source of energy or a chemical source of enemy.

0021An energy storage device, preferably an electric accumulator, may be implantable in the patient for storing the wireless energy released from the external source of energy. The electric accumulator may comprise at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery. Alternatively, a battery may be implantable in the patient for supplying electric energy to implanted electric energy consuming components of the apparatus, in addition to the supply of wireless energy. Where the control device comprises implantable control unit the electronic circuit thereof and the restriction device may be directly powered by transformed wireless energy, or energy from either the implantable energy storage device or battery.

0022In accordance with a second main aspect of the invention, the wireless energy is directly used for operation of the restriction device, i.e. the restriction device is operated as the wireless energy is released from the external source of energy by the control device. In this case the term “directly” is used to mean, on one hand, that the restriction device is promptly operated by using the released energy without first storing the latter, on the other hand, that the released energy may be somewhat delayed, in the order of seconds, by for instance an energy stabilizer before being used for the operation of the restriction device. As a result, a very simple control of the restriction device is achieved and there are only a few implanted components of the apparatus. For example, there is no implanted source of energy, such as a battery, nor any implanted complicated signal control system. This gives the advantage that the apparatus will be extremely reliable.

0023Generally, the control device controls and directly or indirectly powers the operation device with wireless energy released from the source of energy and/or powers other implanted energy consuming components of the apparatus.

0024In a first particular embodiment in accordance with the first and second main aspects of the invention, the operation device comprises a motor, preferably an electric motor which may have electrically conductive parts made of plastics. The motor may include a rotary motor, wherein the control device is adapted to control the rotary motor to rotate a desired number of revolutions. Alternatively, the motor may include a linear motor, or a hydraulic or pneumatic fluid motor, wherein the control device is adapted to control the fluid flow through the fluid motor. Motors currently available on the market are getting smaller and smaller. Furthermore, there is a great variety of control methods and miniaturized control equipment available. For example, a number of revolutions of a rotary motor may be analyzed by a Hall-element just a few mm in size.

0025In a second particular embodiment in accordance with the first and second main aspects of the invention, the control device is adapted to shift polarity of the released energy to reverse the operation device. The operation device may suitably comprise an electric motor and the released energy may comprise electric energy.

0026In a third particular embodiment in accordance with the first and second main aspects of the invention, the restriction device is operable to perform a reversible function and there is a reversing device implantable in the patient for reversing the function performed by the restriction device. Such a reversing function preferably involves enlarging and restricting the urine passageway by the restriction device, suitably in a stepless manner. In this connection, the control device suitably controls the reversing device, which may include a switch, to reverse the function performed by the restriction device. The reversing device may comprise hydraulic means including a valve for shifting the flow direction of a fluid in the hydraulic means. Alternatively, the reversing device may comprise a mechanical reversing device, such as a switch or a gearbox.

0027Where the reversing device comprises a switch the control device suitably controls the operation of the switch by shifting polarity of released energy supplied to the switch. The switch may comprise an electric switch and the source of energy may supply electric energy for the operation of the switch. The switch mentioned above may comprise an electronic switch or, where applicable, a mechanical switch.

0028In accordance with the third particular embodiment, the operation device preferably comprises a motor, wherein the reversing device reverses the motor.

0029In a fourth particular embodiment in accordance with the first and second main aspects of the invention, the restriction device comprises hydraulic means, for example including an expansible/contractible cavity for fluid. Preferably, the operation device is adapted to conduct hydraulic fluid in the hydraulic means, and comprises a motor, a valveless fluid conduit connected to the hydraulic means of the restriction device, and a reservoir for fluid, wherein the reservoir forms part of the conduit. The operation device suitably comprises a pump operated by the motor. All of the hydraulic components involved are preferably devoid of any non-return valve. This is of great advantage, because with valves involved there is always a risk of malfunction due to improperly working valves, especially when long time periods passes between valve operations. The reservoir may form a fluid chamber with a variable volume, and the pump may distribute fluid from the chamber to the hydraulic means of the restriction device by reduction of the volume of the chamber and withdraw fluid from the hydraulic means to the chamber by expansion of the volume of the chamber.

0030In accordance with a third main aspect of the invention, the source of energy is implantable in the patient. Thus, when the source of energy is implanted in a patient the control device controls it from outside the patient's body to release energy. This solution is advantageous for embodiments of the apparatus that have a relatively high consumption of energy, which cannot be satisfied by direct supply of wireless energy.

0031The implantable source of energy may comprise an accumulator, preferably an electric source of energy, such as a battery having a lifetime of at least 10 years.

0032In accordance with a fourth main aspect of the invention, the apparatus comprises a switch implanted in the patient for directly or indirectly switching the operation of the restriction device and an internal source of energy, such as a battery, implanted in the patient for supplying energy for the operation of the restriction device, wherein the switch directly or indirectly affects the supply of energy from the internal source of energy. This solution is advantageous for embodiments of the apparatus that have a relatively high energy consumption which cannot be met by direct supply of wireless energy.

0033In a first particular embodiment in accordance with the fourth main aspect of the invention, the switch switches between an off mode, in which the internal source of energy is not in use, and an on mode, in which the internal source of energy supplies energy for the operation of the restriction device. In this case, the switch is conveniently operated by the wireless energy released from the external source of energy to switch between the on and off modes. The control device, preferably comprising a wireless remote control, may control the external source of energy to release the wireless energy. The advantage of this embodiment is that the lifetime of the implanted source of energy, such as a battery, can be significantly prolonged, since the implanted source of energy does not supply energy when the switch is in its off mode.

0034In a second particular embodiment in accordance with the fourth main aspect of the invention, the control device comprises a wireless remote control for controlling the internal source of energy. In this case, the switch is operable by the wireless energy from the external source of energy to switch between an off mode, in which the internal source of energy and remote control are not in use, and a standby mode, in which the remote control is permitted to control the internal source of energy to supply energy for the operation of the restriction device.

0035In a third particular embodiment in accordance with the fourth main aspect of the invention, the apparatus further comprises an energy transforming device implanted in the patient for transforming the wireless energy into storable energy, wherein the internal source of energy is capable of storing the storable energy. The internal source of energy preferably comprises an electric accumulator, at least one capacitor or at least one rechargeable battery, or a combination of at least one capacitor and at least one rechargeable battery. In this case, the switch switches from an off mode, in which the internal source of energy is not in use, to an on mode, in which the internal source of energy supplies energy for the operation of the restriction device.

0036The control device, preferably comprising a wireless remote control, may control the switch to switch between the on and off modes.

0037Alternatively, in this third particular embodiment an energy storage device may be implanted in the patient for storing the storable energy instead of the internal source of energy, wherein the switch is operable by energy from the implanted energy storage device to switch between an off mode, in which the internal source of energy is not in use, and an on mode, in which the internal source of energy supplies energy for the operation of the restriction device. In this case, the control device (the wireless remote control) controls the energy storage device to operate the switch.

0038The internal source of energy preferably comprises an electric source of energy, such as an accumulator or a battery having a lifetime of at least 10 years. However, other kinds of sources are also conceivable, such as a nuclear source of energy or a chemical source of energy.

0039The above first, second, third and fourth particular embodiments described in connection with the first and second main aspects of the invention are also applicable in accordance with the third main aspect of the invention, i.e. where the source of energy is implantable, and in accordance with the fourth main aspect of the invention, i.e. where the apparatus comprises an implantable switch.

0040All of the above embodiments may be combined with at least one implantable sensor for sensing at least one physical parameter of the patient, wherein the control device may control the restriction device in response to signals from the sensor. For example, the sensor may comprise a pressure sensor for directly or indirectly sensing the pressure in the urethra or urine bladder. The expression “indirectly sensing the pressure in the urethra or urine bladder” should be understood to encompass the cases where the sensor senses the pressure against the restriction device or human tissue of the patient. Where the control device comprises an internal control unit to be implanted in the patient, the internal control unit may suitably directly control the restriction device in response to signals from the sensor. In response to signals from the sensor, for example pressure, the patient's position or any other important physical parameter, the internal control unit may send information thereon to outside the patient's body. The control unit may also automatically control the restriction device in response to signals from the sensor. For example, the control unit may control the restriction device to firmly close the urine passageway in response to the sensor sensing that the patient is lying, or enlarge the urine passageway in response to the sensor sensing an abnormally high pressure against the restriction device.

0041Where the control device comprises an external control unit outside the patient's body, the external control unit may, suitably directly, control the restriction device in response to signals from the sensor. The external control unit may store information on the physical parameter sensed by the sensor and may be manually operated to control the restriction device based on the stored information. In addition, there may be at least one implantable sender for sending information on the physical parameter sensed by the sensor.

0042An external data communicator may be provided outside the patient's body and an internal data communicator to be implanted in the patient may be provided for communicating with the external data communicator. The internal data communicator may feed data related to the patient, or related to the restriction device, back to the external data communicator. Alternatively or in combination, the external data communicator may feed data to the internal data communicator. The internal data communicator may suitably feed data related to at least one physical signal of the patient.

0043Generally, the apparatus of the invention may comprise a switch implantable in the patient for directly or indirectly switching the energy released from the source of energy. For example, the restriction device may be operable to open and close the urine passageway or may steplessly control the restriction of the urine passageway. A pressure sensor may be provided for directly or indirectly sensing the pressure in the urethra or urine bladder. The control device may control the restriction device in response to signals from the pressure sensor.

0044The apparatus may comprise an implantable energy transforming device, wherein the control device releases electric energy and the energy transforming device transforms the electric energy into kinetic energy for, preferably direct, operation of the restriction device. Suitably, an implantable stabilizer, such as a capacitor or a rechargeable accumulator, or the like, may be provided for stabilizing the electric energy released by the control device. In addition, the control device may control the source of energy to release energy for a determined time period or in a determined number of energy pulses. Finally, the restriction device may be non-inflatable.

0045All of the above embodiments are preferably remote controlled. Thus, the control device advantageously comprises a wireless remote control transmitting at least one wireless control signal for controlling the restriction device. With such a remote control it will be possible to adapt the function of the apparatus to the patient's need in a daily basis, which is beneficial with respect to the treatment of the patient.

0046The wireless remote control may be capable of obtaining information on the condition of the restriction device and of controlling the restriction device in response to the information. Also, The remote control may be capable of sending information related to the restriction device from inside the patient's body to the outside thereof.

0047In a particular embodiment of the invention, the wireless remote control comprises at least one external signal transmitter or transceiver and at least one internal signal receiver or transceiver implantable in the patient. In another particular embodiment of the invention, the wireless remote control comprises at least one external signal receiver or transceiver and at least one internal signal transmitter or transceiver implantable the patient.

0048The remote control may transmit a carrier signal for carrying the control signal, wherein the carrier signal is frequency, amplitude or frequency and amplitude modulated and is digital, analog or digital and analog. Also the control signal used with the carrier signal may be frequency, amplitude or frequency and amplitude modulated.

0049The control signal may comprise a wave signal, for example, a sound wave signal, such as an ultrasound wave signal, an electromagnetic wave signal, such as an infrared light signal, a visible light signal, an ultra violet light signal, a laser signal, a micro wave signal, a radio wave signal, an x-ray radiation signal, or a gamma radiation signal. Where applicable, two or more of the above signals may be combined.

0050The control signal may be digital or analog, and may comprise an electric or magnetic field. Suitably, the wireless remote control may transmit an electromagnetic carrier wave signal for carrying the digital or analog control signal. For example, use of an analog carrier wave signal carrying a digital control signal would give safe communication. The control signal may be transmitted in pulses by the wireless remote control.

0051In all of the above solutions, the control device advantageously releases energy from the source of energy in a non-invasive, magnetic, non-magnetic, mechanical or non-mechanical manner.

0052The control device may release magnetic, electromagnetic, kinetic or thermal energy, or non-magnetic, non-thermal, non-electromagnetic or non-kinetic energy.

0053The control device may be activated in a manual or non-manual manner to control the source of energy to release energy.

0054The above-presented embodiments of the invention may be modified in accordance with the following suggestions. The released energy may comprise electric energy and an implantable capacitor having a capacity less than 0.1 μF may be provided for producing the above-mentioned train of energy pulses.

0055An implantable motor or pump may be provided for operating the restriction device, wherein the control device is adapted to control the source of energy to directly power the motor or pump with the released energy. Specifically, the control device may be adapted to release wireless energy in the form of a magnetic field or electromagnetic waves (excluding radio waves) for direct power of the motor or pump, as the wireless energy is being released. Where a pump is used it preferably is not a plunger type of pump.

0056Generally, the wireless energy comprises a signal.

0057The apparatus may further comprise implantable energy transforming device for transforming wireless energy directly or indirectly into energy different than the wireless energy, for operation of the restriction device. For example, the motor or pump may be powered by the transformed energy.

0058The energy transforming device may transform the wireless energy in the form of sound waves, preferably directly, into electric energy for operation of the restriction device. The energy transforming device may comprise a capacitor adapted to produce electric pulses from the transformed electric energy.

0059The motor mentioned in the present specification may also be directly powered with wirelessly transmitted electromagnetic or magnetic energy in the form of signals, as the energy is transmitted. Furthermore, all the various functions of the motor and associated components described in the present specification may be used where applicable.

0060Generally, the restriction device advantageously is embedded in a soft or gel-like material, such as a silicone material having hardness less than 20 Shore.

0061Of course, the restriction device preferably is adjustable in a non-manual manner.

0062All the above described various components, such as the motor, pump and capacitor, may be combined in the different embodiments where applicable. Also the various functions described in connection with the above embodiments of the invention may be used in different applications, where applicable.

0063All the various, ways of transferring energy and controlling the energy presented in the present specification may be practiced by using all of the various components and solutions described.

0064The present invention also provides methods for treating urinary incontinent patients.

0065Accordingly, in accordance with a first alternative method, there is provided a method of treating a patient suffering from urinary incontinence, comprising the steps of implanting an operable restriction device in the patient, so that the restriction device engages the urethra or urine bladder to form a restricted urine passageway in the urethra or urine bladder, providing a source of energy for energizing the restriction device, and controlling the source of energy to release energy for use in connection with the operation of the restriction device. The method may further comprise using energy released from the source of energy to operate the restriction device to open and close, respectively, the urine passageway.

0066In accordance with a second alternative method, there is provided a method of treating a patient suffering from urinary incontinence, comprising the steps of placing at least two laparascopical trocars in the patient's body, inserting a dissecting tool through the trocars and dissecting an area of the urethra or urine bladder, placing an operable restriction device in the dissected area, so that the restriction device engages the urethra or urine bladder to form a restricted urine passageway in the urethra or urine bladder, implanting a source of energy in the patient, and controlling the implanted source of energy from outside the patient's body to release energy for use in connection with the operation of the restriction device.

0067In accordance with a third alternative method, there is provided a method of treating a patient suffering from urinary incontinence, comprising: (a) Surgically implanting in the patient an operable restriction device engaging the patient's urethra or urine bladder to form a restricted urine passageway in the urethra or urine bladder. (b) Providing a source of energy external to the patient's body. (c) Controlling the external source of energy from outside the patient's body to release wireless energy. And (d) using the released wireless energy in connection with the operation of the restriction device.

0068The method may further comprise (e) implanting in the human or animal an operation device which can adjust the restricted urine passageway in response to supplied energy, and (f) using the released wireless energy to activate the implanted operation device so as (i) to enlarge the restricted urine passageway to allow urine to readily pass therethrough but normally restrict the urine passageway. In the method (f) may be practiced at least once a day, normally several times (e.g. 2-10) a day.

0069In accordance with a fourth alternative method, there is provided a method of treating a patient suffering from urinary incontinence, comprising the steps of placing at least two laparascopical trocars in the patient's body, inserting a dissecting tool through the trocars and dissecting an area of the urethra or urine bladder, placing an operable restriction device in the dissected area, so that the restriction device engages the urethra or urine bladder to form a restricted urine passageway in the urethra or urine bladder, providing an external source of energy outside the patient's body, controlling the external source of energy from outside the patient's body to release wireless energy, and using the released wireless energy in connection with the operation of the restriction device.

0070In accordance with a fifth alternative method, there is provided a method of treating a patient suffering from urinary incontinence, comprising the steps of placing at least two laparascopical trocars in the patient's body, inserting a dissecting tool through the trocars and dissecting an area of the urethra or urine bladder, implanting an operable restriction device in the dissected area, so that the restriction device engages the urethra or urine bladder to form a restricted urine passageway in the urethra or urine bladder, implanting an energy transforming device, providing an external source of energy, controlling the external source of energy to release wireless energy, and transforming the wireless energy by the energy transforming device into energy different than the wireless energy for use in connection with the operation of the restriction device. This method may further comprise implanting a stabilizer in the patient for stabilizing the energy transformed by the energy transforming device.

0071The invention is described in more detail in the following with reference to the accompanying drawings, in which

0072<figref idref="DRAWINGS">FIGS. 1 to 6</figref> are schematic block diagrams illustrating six embodiments, respectively, of the invention, in which wireless energy released from an external source of energy is used for direct operation of a restriction device engaging the urethra or urine bladder of a patient;

0073<figref idref="DRAWINGS">FIGS. 7 to 10</figref> are schematic block diagrams illustrating four embodiments, respectively, of the invention, in which energy is released from an implanted source of energy;

0074<figref idref="DRAWINGS">FIGS. 11 to 15</figref> are schematic block diagrams illustrating five embodiments, respectively, of the invention, in which a switch is implanted in the patient for directly or indirectly switching the operation of the restriction device;

0075<figref idref="DRAWINGS">FIG. 16</figref> is a schematic block diagram illustrating conceivable combinations of implantable components for achieving various communication options;

0076<figref idref="DRAWINGS">FIG. 17</figref> illustrates the apparatus in accordance with the invention implanted in a patient;

0077<figref idref="DRAWINGS">FIG. 18</figref> is a block diagram illustrating remote control components of an embodiment of the invention; and

0078<figref idref="DRAWINGS">FIG. 19</figref> is a schematic view of exemplary circuitry used for the components of the block diagram of <figref idref="DRAWINGS">FIG. 18</figref>.

0079Referring to the drawing figures, like reference numerals designate identical or corresponding elements throughout the several figures.

0080<figref idref="DRAWINGS">FIG. 1</figref> schematically shows an embodiment of the urinary incontinence treatment apparatus of the invention having some parts implanted in a patient and other parts located, outside the patient's body. Thus, in <figref idref="DRAWINGS">FIG. 1</figref> all parts placed to the right of the patient's skin <b>2</b> are implanted and all parts placed to the left of the skin <b>2</b> are located outside the patient's body. The apparatus of <figref idref="DRAWINGS">FIG. 1</figref> comprises an implanted operable restriction device <b>4</b>, which engages the patient's urethra (or alternatively the urine bladder) to form a restricted urine passageway. The restriction device <b>4</b> is capable of performing a reversible function, i.e. to open and close the urine passageway. An implanted control unit <b>6</b> controls the restriction device <b>4</b> via a control line <b>8</b> to form an adequate restriction of the of the urine passageway. An external control unit <b>10</b> includes an external source of energy and a wireless remote control transmitting a control signal generated by the external source of energy. The control signal is received by a signal receiver incorporated in the implanted control unit <b>6</b>, whereby the control unit <b>6</b> controls the implanted restriction device <b>4</b> in response to the control signal. The implanted control unit <b>6</b> also uses energy from the control signal for operating the restriction device <b>4</b> via a power supply line <b>12</b>.

0081<figref idref="DRAWINGS">FIG. 2</figref> shows an embodiment of the invention identical to that of <figref idref="DRAWINGS">FIG. 1</figref>, except that a reversing device in the form of a switch <b>14</b> operable by energy also is implanted in the patient for reversing the restriction device <b>4</b>. The control unit <b>6</b> uses the switch <b>14</b> to reverse the function performed by the restriction device <b>4</b>. More precisely, the external control unit <b>10</b> releases energy carried by a wireless signal and the implanted control unit <b>6</b> transforms the wireless energy into a current for operating the switch <b>14</b>. When the control unit <b>6</b> shifts the polarity of the current the switch <b>14</b> reverses the function performed by the restriction device <b>4</b>.

0082<figref idref="DRAWINGS">FIG. 3</figref> shows an embodiment of the invention identical to that of <figref idref="DRAWINGS">FIG. 1</figref>, except that an operation device in the form of a motor <b>16</b> also is implanted in the patient. The implanted control unit <b>6</b> powers the motor <b>16</b> with wireless energy released from the external source of energy of the external control unit <b>10</b>. The implanted control unit <b>6</b> controls the operation of the motor <b>16</b> in response to a control signal from the remote control of the external control unit <b>10</b>.

0083<figref idref="DRAWINGS">FIG. 4</figref> shows an embodiment of the invention identical to that of <figref idref="DRAWINGS">FIG. 1</figref>, except that an assembly <b>16</b> including a motor/pump unit <b>18</b> and a fluid reservoir <b>20</b> also is implanted in the patient. In this case the restriction device <b>4</b> is hydraulically operated, i.e. hydraulic fluid is pumped by the motor/pump unit <b>18</b> from the reservoir <b>20</b> through a conduit <b>22</b> to the restriction device <b>4</b> to restrict the urine passageway, and hydraulic fluid is pumped by the motor/pump unit <b>18</b> back from the restriction device <b>4</b> to the reservoir <b>20</b> to enlarge the urine passageway. The external control unit <b>10</b> releases energy carried by a wireless signal and the implanted control unit <b>6</b> transforms the wireless energy into a current, for example a current, for powering the motor/pump unit <b>18</b> via an electric power supply line <b>24</b>. The implanted control unit <b>6</b> controls the motor/pump unit <b>16</b> and the restriction device <b>4</b> via control lines <b>26</b> and <b>27</b>.

0084<figref idref="DRAWINGS">FIG. 5</figref> shows an embodiment of the invention comprising the restriction device <b>4</b>, hydraulically operated, and the implanted control unit <b>6</b>, and further comprising a hydraulic fluid reservoir <b>230</b>, a motor/pump unit <b>232</b> and a reversing device in the form of a hydraulic valve shifting device <b>234</b>, all of which are implanted in the patient. The motor of the motor/pump unit <b>232</b> is an electric motor.

0085<figref idref="DRAWINGS">FIG. 6</figref> shows an embodiment of the invention identical to that of <figref idref="DRAWINGS">FIG. 1</figref>, except that an accumulator <b>28</b> also is implanted in the patient. The control unit <b>6</b> stores energy received from the external control unit <b>10</b> in the accumulator <b>28</b>. In response to a control signal from the external control unit <b>10</b> the implanted control unit <b>6</b> releases energy from the accumulator <b>28</b> via a power-line <b>30</b> for the operation of the restriction device <b>4</b>.

0086<figref idref="DRAWINGS">FIG. 7</figref> shows an embodiment of the invention comprising the restriction device <b>4</b>, hydraulically operated, and the implanted control unit <b>6</b>, and further comprising a source of energy in the form of a battery <b>32</b>, a hydraulic fluid reservoir <b>34</b>, a motor/pump unit <b>36</b> and a reversing device in the form of a hydraulic valve shifting device <b>38</b>, all of which are implanted in the patient. The motor of the motor/pump unit <b>36</b> is an electric motor. An external control unit <b>40</b> includes a wireless remote control transmitting a control signal which is received by the signal receiver incorporated in the implanted control unit <b>6</b>.

0087In response to a control signal from the external control unit <b>40</b> the implanted control unit <b>6</b> powers the motor/pump unit <b>36</b> with energy from the battery <b>32</b>, whereby the motor/pump unit <b>36</b> distributes hydraulic fluid between the reservoir <b>34</b> and the restriction device <b>4</b>. The control unit <b>6</b> controls the shifting device <b>38</b> to shift the hydraulic fluid flow direction between one direction in which the fluid is pumped by the motor/pump unit <b>36</b> from the reservoir <b>34</b> to the restriction device <b>4</b> to restrict the urine passageway, and another opposite direction in which the fluid is pumped by the motor/pump unit <b>36</b> back from the restriction device <b>4</b> to the reservoir <b>34</b> to enlarge the urine passageway.

0088<figref idref="DRAWINGS">FIG. 8</figref> shows an embodiment of the invention identical to that of <figref idref="DRAWINGS">FIG. 6</figref>, except that a battery <b>42</b> is substituted for the accumulator <b>28</b>, the external control unit <b>40</b> of the embodiment of <figref idref="DRAWINGS">FIG. 5</figref> is substituted for the external control unit <b>10</b> and an electric motor <b>44</b> is implanted in the patient for operating the restriction device <b>4</b>. In response to a control signal from the external control unit <b>40</b> the implanted control unit <b>6</b> powers the motor <b>44</b> with energy from the battery <b>42</b>, whereby the motor <b>44</b> operates the restriction device <b>4</b>.

0089<figref idref="DRAWINGS">FIG. 9</figref> shows an embodiment of the invention identical to that of <figref idref="DRAWINGS">FIG. 8</figref>, except that the motor/pump unit <b>36</b> of the embodiment of <figref idref="DRAWINGS">FIG. 7</figref> is substituted for the motor <b>44</b> and a fluid reservoir <b>46</b> also is implanted in the patient. The reservoir <b>46</b> is via fluid conduits <b>48</b> and <b>50</b> connected to the motor/pump unit <b>36</b> and restriction device <b>4</b>, which in this case is hydraulically operated. In response to a control signal from the external control unit <b>40</b>, the implanted control unit <b>6</b> powers the electric motor of the motor/pump unit <b>36</b> with energy from the battery <b>42</b>, whereby the motor/pump unit <b>36</b> distributes hydraulic fluid between the fluid reservoir <b>46</b> and the restriction device <b>4</b>.

0090<figref idref="DRAWINGS">FIG. 10</figref> shows an embodiment of the invention identical to that of <figref idref="DRAWINGS">FIG. 8</figref>, except that a mechanical reversing device in the form of a gearbox <b>52</b> also is implanted in the patient. The implanted control unit <b>6</b> controls the gearbox <b>52</b> to reverse the function performed by the restriction device <b>4</b> (mechanically operated).

0091<figref idref="DRAWINGS">FIG. 11</figref> shows an embodiment of the invention comprising the restriction device <b>4</b>, the external control unit <b>10</b>, an implanted source of energy <b>236</b> and an implanted switch <b>238</b>. The switch <b>238</b> is operated by wireless energy released from the external source of energy of the external control unit <b>6</b> to switch between an off mode, in which the implanted source of energy <b>236</b> is not in use, and an on mode, in which the implanted source of energy <b>236</b> supplies energy for the operation of the restriction device <b>4</b>.

0092<figref idref="DRAWINGS">FIG. 12</figref> shows an embodiment of the invention identical to that of <figref idref="DRAWINGS">FIG. 11</figref>, except that also the control unit <b>6</b> is implanted, in order to receive a control signal from the wireless remote control of the external control unit <b>10</b>. The switch <b>238</b> is operated by the wireless energy from the external source of energy <b>10</b> to switch between an off mode, in which the implanted source of energy <b>236</b> and the wireless remote control of the external control unit <b>10</b> are not in use, i.e. the control unit <b>6</b> is not capable of receiving the control signal, and a standby mode, in which the wireless remote control is permitted to control the internal source of energy <b>236</b>, via the implanted control unit <b>6</b>, to supply energy for the operation of the restriction device <b>4</b>.

0093<figref idref="DRAWINGS">FIG. 13</figref> shows an embodiment of the invention identical to that of <figref idref="DRAWINGS">FIG. 12</figref>, except that an energy transforming device for transforming the wireless energy into storable energy is incorporated in the implanted control unit <b>6</b> and that the implanted source of energy <b>236</b> is of a type that is capable of storing the storable energy. In this case, in response to a control signal from the external control unit <b>10</b>, the implanted control unit <b>6</b> controls the switch <b>238</b> to switch from an off mode, in which the implanted source of energy <b>236</b> is not in use, to an on mode, in which the source of energy <b>36</b> supplies energy for the operation of the restriction device <b>4</b>.

0094<figref idref="DRAWINGS">FIG. 14</figref> shows an embodiment of the invention identical to that of <figref idref="DRAWINGS">FIG. 13</figref>, except that an energy storage device <b>240</b> also is implanted in the patient for storing the storable energy transformed from the wireless energy by the transforming device of the control unit <b>6</b>. In this case, the implanted control unit <b>6</b> controls the energy storage device <b>240</b> to operate the switch <b>238</b> to switch between an off mode, in which the implanted source of energy <b>236</b> is not in use, and an on mode, in which the implanted source of energy <b>236</b> supplies energy for the operation of the restriction device <b>4</b>.

0095<figref idref="DRAWINGS">FIG. 15</figref> shows an embodiment of the invention identical to that of <figref idref="DRAWINGS">FIG. 13</figref>, except that a motor <b>242</b> and a mechanical reversing device in the form of a gearbox <b>244</b> also are implanted in the patient. The implanted control unit <b>6</b> controls the gearbox <b>244</b> to reverse the function performed by the restriction device <b>4</b> (mechanically operated), i.e. enlarging and restricting the urine passageway.

0096<figref idref="DRAWINGS">FIG. 16</figref> schematically shows conceivable combinations of implanted components of the apparatus for achieving various communication possibilities. Basically, there are the implanted restriction device <b>4</b>, the implanted control unit <b>6</b> and the external control unit <b>10</b> including the external source of energy and the wireless remote control. As already described above the remote control transmits a control signal generated by the external source of energy, and the control signal is received by a signal receiver incorporated in the implanted control unit <b>6</b>, whereby the control unit <b>6</b> controls the implanted restriction device <b>4</b> in response to the control signal.

0097A sensor <b>54</b> may be implanted in the patient for sensing a physical parameter of the patient, such as the pressure in the stomach. The control unit <b>6</b>, or alternatively the external control unit <b>10</b>, may control the restriction device <b>4</b> in response to signals from the sensor <b>54</b>. A transceiver may be combined with the sensor <b>54</b> for sending information on the sensed physical parameter to the external control unit <b>10</b>. The wireless remote control of the external control unit <b>10</b> may comprise a signal transmitter or transceiver and the implanted control unit <b>6</b> may comprise a signal receiver or transceiver. Alternatively, the wireless remote control of the external control unit <b>10</b> may comprise a signal receiver or transceiver and the implanted control unit <b>6</b> may comprise a signal transmitter or transceiver. The above transceivers, transmitters and receivers may be used for sending information or data related to the restriction device from inside the patient's body to the outside thereof.

0098The motor <b>44</b> may be implanted for operating the restriction device <b>4</b> and also the battery <b>32</b> may be implanted for powering the motor <b>44</b>. The battery <b>32</b> may be equipped with a transceiver for sending information on the charge condition of the battery.

0099Those skilled in the art will realize that the above various embodiments according to <figref idref="DRAWINGS">FIGS. 1-15</figref> could be combined in many different ways. For example, the energy operated switch <b>14</b> could be incorporated in any of the embodiments of FIGS. <b>4</b>,<b>6</b>,<b>8</b>-<b>10</b>. The hydraulic shifting device <b>38</b> could be incorporated in any of the embodiments of <figref idref="DRAWINGS">FIGS. 4 and 9</figref>. The gearbox <b>52</b> could be incorporated in any of the embodiments of FIGS. <b>1</b>,<b>6</b> and <b>8</b>.

0100<figref idref="DRAWINGS">FIG. 17</figref> illustrates how any of the above-described embodiments of the apparatus of the invention may be implanted in a patient. Thus, an assembly of the apparatus implanted in the patient comprises a restriction device <b>56</b> engaging the urethra <b>58</b>, an operation device <b>60</b> for operating the restriction device <b>56</b> and an internal control unit <b>62</b>, which includes a signal receiver, for controlling the operation device <b>61</b>. An external control unit <b>64</b> includes a signal transmitter for transmitting a wireless control signal to the signal receiver of the implanted control unit <b>62</b>. The implanted control unit <b>62</b> is capable of transforming signal energy from the control signal into electric energy for powering the operation device <b>60</b> and for energizing energy consuming implanted components of the apparatus.

0101<figref idref="DRAWINGS">FIG. 18</figref> shows the basic parts of a wireless remote control of the apparatus of the invention including an electric motor <b>128</b> for operating a restriction device, for example of the type illustrated in <figref idref="DRAWINGS">FIG. 17</figref>. In this case, the remote control is based on the transmission of electromagnetic wave signals, often of high frequencies in the order of 100 kHz-1 gHz, through the skin <b>130</b> of the patient. In <figref idref="DRAWINGS">FIG. 18</figref>, all parts placed to the left of the skin <b>130</b> are located outside the patient's body and all parts placed to the right of the skin <b>130</b> are implanted. Any suitable remote control system may be used.

0102An external signal transmitting antenna <b>132</b> is to be positioned close to a signal receiving antenna, <b>134</b> implanted close to the skin <b>130</b>. As an alternative, the receiving antenna <b>134</b> may be placed for example inside the abdomen of the patient. The receiving antenna <b>134</b> comprises a coil, approximately 1-100 mm, preferably 25 mm in diameter, wound with a very thin wire and tuned with a capacitor to a specific high frequency. A small coil is chosen if it is to be implanted under the skin of the patient and a large coil is chosen if it is to be implanted in the abdomen of the patient. The transmitting antenna <b>132</b> comprises a coil having about the same restriction as the coil of the receiving antenna <b>134</b> but wound with a thick wire that can handle the larger currents that is necessary. The coil of the transmitting antenna <b>132</b> is tuned to the same specific high frequency as the coil of the receiving antenna <b>134</b>.

0103An external control unit <b>136</b> comprises a microprocessor, a high frequency electromagnetic wave signal generator and a power amplifier. The microprocessor of the control unit <b>136</b> is adapted to switch the generator on/off and to modulate signals generated by the generator to send digital information via the power amplifier and the antennas <b>132</b>,<b>134</b> to an implanted control unit <b>138</b>. To avoid that accidental random high frequency fields trigger control commands, digital signal codes are used. A conventional keypad placed on the external control unit <b>136</b> is connected to the microprocessor thereof. The keypad is used to order the microprocessor to send digital signals to activate the restriction device to either restrict or enlarge the urine passageway. The microprocessor starts a command by applying a high frequency signal on the antenna <b>132</b>. After a short time, when the signal has energized the implanted parts of the control system, commands are sent to restrict or enlarge the urine passageway in predefined steps. The commands are sent as digital packets in the form illustrated below.

0104<tables id="TABLE-US-00001" num="00001"><table frame="none" colsep="0" rowsep="0"><tgroup align="left" colsep="0" rowsep="0" cols="5"><colspec colname="offset" colwidth="14pt" align="left" /><colspec colname="1" colwidth="49pt" align="left" /><colspec colname="2" colwidth="56pt" align="left" /><colspec colname="3" colwidth="42pt" align="left" /><colspec colname="4" colwidth="56pt" align="left" /><thead><row><entry /><entry namest="offset" nameend="4" align="center" rowsep="1" /></row></thead><tbody valign="top"><row><entry /><entry>Start pattern,</entry><entry>Command,</entry><entry>Count,</entry><entry>Checksum,</entry></row><row><entry /><entry>8 bits</entry><entry>8 bits</entry><entry>8 bits</entry><entry>8 bits</entry></row><row><entry /><entry namest="offset" nameend="4" align="center" rowsep="1" /></row></tbody></tgroup></table></tables>

0105The commands are sent continuously during a rather long time period (e.g. about 30 seconds or more). When a new restrict or enlarge step is desired the Count byte is increased by one to allow the implanted control unit <b>138</b> to decode and understand that another step is demanded by the external control unit <b>136</b>. If any part of the digital packet is erroneous, its content is simply ignored.

0106Through a line <b>140</b>, an implanted energizer unit <b>126</b> draws energy from the high frequency electromagnetic wave signals received by the receiving antenna <b>134</b>. The energizer unit <b>126</b> stores the energy in a power supply, such as a large capacitor, powers the control unit <b>138</b> and powers the electric motor <b>128</b> via a line <b>142</b>.

0107The control unit <b>138</b> comprises a demodulator and a microprocessor. The demodulator demodulates digital signals sent from the external control unit <b>136</b>. The microprocessor of the control unit <b>138</b> receives the digital packet, decodes it and, provided that the power supply of the energizer unit <b>126</b> has sufficient energy stored, sends a signal via a signal line <b>144</b> to the motor <b>128</b> to either contract or enlarge the restriction device depending on the received command code.

0108Alternatively, the energy stored in the power supply of the energizer unit may only be used for powering a switch, and the energy for powering the motor <b>128</b> may be obtained from another implanted power source of relatively high capacity, for example a battery. In this case the switch is adapted to connect said battery to the control unit <b>138</b> in an on mode when said switch is powered by said power supply and to keep said battery disconnected from the control unit in a standby mode when said switch is unpowered.

0109With reference to <figref idref="DRAWINGS">FIG. 19</figref>, the remote control schematically described above will now be described in accordance with a more detailed embodiment. The external control unit <b>136</b> comprises a microprocessor <b>146</b>, a signal generator <b>148</b> and a power amplifier <b>150</b> connected thereto. The microprocessor <b>146</b> is adapted to switch the signal generator <b>148</b> on/off and to modulate signals generated by the signal generator <b>148</b> with digital commands that are sent to implanted components of the apparatus. The power amplifier <b>150</b> amplifies the signals and sends them to the external signal transmitting antenna <b>132</b>. The antenna <b>132</b> is connected in parallel with a capacitor <b>152</b> to form a resonant circuit tuned to the frequency generated by the signal generator <b>148</b>.

0110The implanted signal receiving antenna coil <b>134</b> forms together with a capacitor <b>154</b> a resonant circuit that is tuned to the same frequency as the transmitting antenna <b>132</b>. The signal receiving antenna coil <b>134</b> induces a current from the received high frequency electromagnetic waves and a rectifying diode <b>160</b> rectifies the induced current, which charges a storage capacitor <b>158</b>. A coil <b>156</b> connected between the antenna coil <b>134</b> and the diode <b>160</b> prevents the capacitor <b>158</b> and the diode <b>160</b> from loading the circuit of the signal receiving antenna <b>134</b> at higher frequencies. Thus, the coil <b>156</b> makes it possible to charge the capacitor <b>158</b> and to transmit digital information using amplitude modulation.

0111A capacitor <b>162</b> and a resistor <b>164</b> connected in parallel and a diode <b>166</b> forms a detector used to detect amplitude modulated digital information. A filter circuit is formed by a resistor <b>168</b> connected in series with a resistor <b>170</b> connected in series with a capacitor <b>172</b> connected in series with the resistor <b>168</b> via ground, and a capacitor <b>174</b>, one terminal of which is connected between the resistors <b>168</b>,<b>170</b> and the other terminal of which is connected between the diode <b>166</b> and the circuit formed by the capacitor <b>162</b> and resistor <b>164</b>. The filter circuit is used to filter out undesired low and high frequencies. The detected and filtered signals are fed to an implanted microprocessor <b>176</b> that decodes the digital information and controls the motor <b>128</b> via an H-bridge <b>178</b> comprising transistors <b>180</b>,<b>182</b>,<b>184</b> and <b>186</b>. The motor <b>128</b> can be driven in two opposite directions by the H-bridge <b>178</b>.

0112The microprocessor <b>176</b> also monitors the amount of stored energy in the storage capacitor <b>158</b>. Before sending signals to activate the motor <b>128</b>, the microprocessor <b>176</b> checks whether the energy stored in the storage capacitor <b>158</b> is enough. If the stored energy is not enough to perform the requested operation, the microprocessor <b>176</b> waits for the received signals to charge the storage capacitor <b>158</b> before activating the motor <b>128</b>.